Greenblum & Bernstein, P.L.C.
PRACTICE GROUP NEWSLETTER
Recent News in Intellectual Property
In This Issue
· District Court Finds Inducement To Infringe Found In Doxercalciferol® Case
· Federal Circuit Upholds First Post- Therasense Inequitable Conduct Ruling In Taxotere® Case
District Court Finds Inducement To Infringe In Doxercalciferol® Case
The U.S. District Court for the District of Delaware recently held, inter alia, in Bone Care Int'l v. Roxane Labs., that the ANDA applicants’, i.e., Roxane, Sandoz, and Anchen, generic products would induce infringement of claim 7 of U.S. Patent No. 5,602,116 (“the ‘116 patent”), and that the claim was not invalid. This litigation stems from the applicants ANDA containing a paragraph IV certification seeking approval to market generic version of Hectorol® (doxercalciferol), which is indicated and approved for the treatment of secondary hyperparathyroidism (“SHPT”) in patients with end-stage renal disease (“ESRD”).
The District Court conducted a Markman hearing and in relevant part, construed the term "effective amount of doxercalciferol to lower and maintain lowered serum parathyroid hormone levels" to mean "an amount of doxercalciferol sufficient to lower and maintain lowered blood concentrations of PTH with a lower incidence of hypercalcemia than would result from using calcitriol or alfacalcidol to achieve the same level of PTH suppression." The District Court thereafter undertook the inducement to infringement analysis first concluding that claim 7 would be directly infringed by applicants' ANDA products. After making this necessary underlying finding for inducement to infringe, the District Court turned to the second prong of the test; that is, whether applicants had the requisite specific intent to induce infringement.
The intent question turned on whether applicants intended to induce infringement of claim 7; despite the fact that the proposed ANDA labeling did not discuss or compare the incidence of hypercalcemia resulting from doxercalciferol as opposed to those from calcitriol or alfacalcidol. To answer this question, the District Court first noted that (although the threshold infringement question in Hatch-Waxman litigations is "whether the proposed label instructs users to perform the patented method," and "promotes" or "encourages" others to practice that method) the Federal Circuit has held that inducement to infringe also requires a showing of evidence that the applicant "knew or should have known that his actions would induce actual infringement" and "that the induced acts constitute patent infringement." That is, the Federal Circuit has held that inducement required determining whether the proposed label "instructs users to perform the patented method" and "teaches an infringing use . . . such that we are willing to infer from those instructions an affirmative intent to infringe the patent."
The District Court then turned to the facts at-hand and concluded that the Bone Care had shown that applicants "knew or should have known their actions would induce actual infringements," because all of the ANDAs sought approval to market a doxercalciferol product with a label directing physicians and medical professionals to administer in accordance with the claimed method; the FDA-approved indication is the same use set forth in the claim. The District Court, in making this finding, also relied upon publically available clinical trials and literature to show that applicants knew or should have known that doxercalciferol has been shown to lower and maintain PTH levels with a diminished incidence of hypercalcemia than would result from using calcitriol or alfacalcidol at the same level of PTH suppression.
Federal Circuit Upholds First Post-Therasense Inequitable Conduct Ruling In Taxotere® Case
The Federal Circuit recently affirmed the ruling by the U.S. District Court for the District of Delaware in Aventis Pharma v. Hospira that U.S. Patent No. 5,750,561 (“the ‘561 patent”) and U.S. Patent No. 5,714,512 (“the ‘512 patent”) (collectively “the Aventis patents”) were, inter alia, unenforceable for inequitable conduct. After a bench trial, the District Court held the Aventis patents unenforceable prior to the Federal Circuit’s ruling in Therasence which changed the standard for inequitable conduct, as well as holding certain asserted claims invalid as obvious and/or non-infringed.
The Aventis patents are directed to the chemotherapy drug Taxotere®, i.e., formulations of the cancer drug docetaxel that minimize stability and toxicity problems in prior art formulations with certain surfactants/excipients and limited ethanol. The District Court held the Aventis patents unenforceable based upon the intentional non-disclosure of a publication by Guéritte-Voegelein (“the GV reference”) and the Dictionnaire Vidal (“the Vidal reference”).
In affirming the District Court, the Federal Circuit expressly noted that “although the district court did not have the benefit of our Therasense opinion when it rendered its inequitable conduct decision, . . . we conclude [based upon an analysis of both the materiality and intent to deceive prongs of the inequitable conduct test] that the [district] court’s inequitable conduct determination withstands even the more rigorous standard adopted in Therasense.”
With respect to analysis itself, the Federal Circuit first addressed the materiality prong observing that the inequitable conduct assertions were based upon the exact same two invalidating references, and that under Therasense, the invalidity rulings establish that the GV and Vidal references meet the “but for” test for materiality. In so doing, the Federal Circuit quoted the following passage from Therasense:
[W]hen a “claim is properly invalidated in district court based on the deliberately withheld reference, then that reference is necessarily material” for purposes of the inequitable conduct inquiry.
The Federal Circuit then turned its attention to the intent prong noting the test, which requires that: (1) the accused infringer prove by clear and convincing evidence that applicant knew of the reference, knew that it was material, and made a deliberate and intentional decision to withhold it; and (2) applicant’s specific intent to deceive must be “the single most reasonable inference able to be drawn from the evidence.”
With regard to the Vidal reference, the Federal Circuit agreed with the District Court discounting, as not credible, the inventor’s testimony that he believed that it was not necessary to disclose the Vidal reference because his related experiments were “failures.” In so doing, the Federal Circuit relied upon the grounds that the inventor himself provided contradictory testimony elsewhere that he learned from the Vidal reference to replace the prior art surfactant with the claimed surfactant, and that the Vidal reference was a “main factor” in replacing the surfactant, which both noted “was consistent with [an Aventis] internal memorandum.” The Federal Circuit also joined in the District Court’s concerns that the inventors had mischaracterized the Vidal reference as recognizing a problem with the prior art surfactant but not a possible solution, in holding that the inventors acted with intent because they “knew that the Vidal reference and the other etoposide prior art were relevant to the patentability of his alleged invention, but nonetheless chose not to disclose it to the patent office.”
The Federal Circuit also agreed with the District Court in finding not credible the inventor’s testimony that he did not disclose the GV reference because he only had read a draft that did not include the most relevant passage because, inter alia, the inventor: (1) “was the project leader;” (2) “had to approve the GV reference for publication;” and (3) “had testified that he reviewed the article ‘with some care to make sure that it was a proper article for the company to be publishing.’” The Federal Circuit further observed as did the District Court the inventor’s testimony that he took steps to revise the clinical brochure for Taxotere® because it did not list the GV reference, yet did not disclose the GV reference to the U.S. Patent Office.
In view of the above, the Federal Circuit held that “the district court heard extensive testimony from inventor Fabre regarding both the Vidal and GV references, and the court’s finding that Fabre acted with a specific intent to deceive the PTO in withholding those references is not clearly erroneous.”